USHIFU STEPPER
Device Facts
| Record ID | K080970 |
|---|---|
| Device Name | USHIFU STEPPER |
| Applicant | Ushifu Development Company, LLC |
| Product Code | ITX · Radiology |
| Decision Date | Jun 11, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
Indications for Use
The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging.
Device Story
USHIFU Stepper is a mechanical, manually controlled device designed to support and stabilize ultrasonic probes during prostate imaging. It allows for finite horizontal and vertical adjustments. The device is constructed from lightweight materials and is designed to be pre-assembled and attached to a surgical table. It is operated by clinical staff in a medical setting to facilitate stable imaging procedures.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Mechanical, manually controlled device for ultrasonic probe stabilization. Features horizontal and vertical adjustment planes. Constructed from lightweight materials. Attaches to surgical tables.
Indications for Use
Indicated for patients undergoing prostate imaging requiring ultrasonic probe support and stabilization.
Regulatory Classification
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Predicate Devices
- Super Scan/Biopsy Guide, CIVCO (K843573)
Submission Summary (Full Text)
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K080870
Submitter:
USHIFU, LLC
USHIFU Stepper
Traditional 510(k)
## 510(k) SUMMARY
| | JUN 1 1 2008 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name: | USHIFU, LLC |
| Submitter Address: | 1450 South Woodland Blvd. |
| | DeLand, FL 32720 |
| Contact Person: | Mare Ryan |
| | Vice President of Regulatory Affairs |
| Phone Number: | 386.785.0100 |
| Fax Number: | 386.785.0101 |
| Date Prepared: | April 4, 2008 |
| Device Trade Name: | USHIFU Stepper |
| Device Common Name: | Ultrasound Probe Stepper |
| Classification Number: | 21 CFR 892.1570 |
| Classification Name: | Transducer, Ultrasonic, Diagnostic |
| Product Code: | ITX |
| Predicate Device: | K843573, Super Scan/Biopsy Guide, CIVCO |
| Statement of Intended Use: | The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging. |
| Device Description: | The USHIFU Stepper is a mechanical device which is manually controlled in the horizontal and vertical directions. It is designed to allow for finite adjustments in these planes. It is composed of light-weight materials, is pre-assembled and easily attached to a surgical table. |
| Comparison to the Predicate Device: | Based upon the intended use, design, and composition (materials), it can be concluded the USHIFU Stepper is substantially equivalent to the predicate device in terms of intended use, safety and effectiveness. |
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Mare Ryan Vice President, Regulatory Affairs USHIFU Development Company, LLC 1450 South Woodland Blvd. DELAND FL 32720
Re: K080970
Trade/Device Name: USHIFU Stepper Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: April 4, 2008 Received: April 4, 2008
Dear Ms. Ryan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good voanufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your do roo is olastilia (50 such additional controls. Existing major regulations affecting your Apple rar, to they of boole of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the federal Register.
Image /page/1/Picture/10 description: The image is a circular logo with the text "FDA Centennial" and the years "1906-2006" displayed. The logo features the letters "FDA" in a stylized font, with the word "Centennial" written below. The logo is surrounded by a circular border with text and stars.
Protecting and Promoting Public Health
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and liasting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ecctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to Ivgally marketed predicate device results in a classification for your device and thus, perceite your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance a one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892:xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillonce at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device Leporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may other other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 63-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrhindustry/support/index.html i
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Submitter: USHIFU, LLC
K080970
510(k) Number (if known):
Device Name:
USHIFU Stepper
Indications for Use:
The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
## Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
-
Hedin Reimer
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
